Furosemid hameln

Leaflet accompanying the packaging: patient information

Furosemid hameln, 10 mg/ml, solution for injection

Furosemide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Furosemid hameln and what is it used for
• 2. Important information before using Furosemid hameln
• 3. How to use Furosemid hameln
• 4. Possible side effects
• 5. How to store Furosemid hameln
• 6. Contents of the packaging and other information

1. What is Furosemid hameln and what is it used for

Furosemid hameln contains the active substance furosemide, which belongs to a group of medicines called diuretics or water pills.
Furosemid hameln is used to quickly remove excess water from the body. It is given if the patient cannot take tablets or if there is too much water in the body. Furosemid hameln is often used if excess water accumulates around the heart, lungs, liver, or kidneys.

2. Important information before using Furosemid hameln

When not to use Furosemid hameln

• If the patient is allergic to furosemide or any of the other ingredients of this medicine (listed in section 6). If the patient is allergic to sulfonamide medicines (e.g. cotrimoxazole, sulfadiazine), sulfonamide derivatives, or amiloride, they may also be allergic to Furosemid hameln.
• If the patient is dehydrated, has a low blood volume (may cause dizziness, fainting, or pale skin) or if the patient is unable to urinate.
• If the patient has low levels of potassium or sodium in the blood or other electrolyte disorders in the blood (detected by blood tests).
• If the patient has severe liver disease (cirrhosis) affecting consciousness.
• If the patient has been given certain medicines in the past that have caused liver or kidney damage.
• If the patient has used furosemide in the past to treat difficulty urinating or kidney failure, or if the patient has kidney failure caused by liver dysfunction.
• If the patient has Addison's disease, which can cause fatigue and weakness.
• If the patient is taking digitalis preparations, digoxin, heart glycosides to treat heart disease.
• If the patient has porphyria, which can cause abdominal pain, vomiting, or muscle weakness.
• If the patient is breastfeeding.

Warnings and precautions

Before starting treatment with Furosemid hameln, discuss it with your doctor or nurse:

• If the patient has low blood pressure (hypotension) or feels dizzy when standing up.
• If the patient feels dizzy or is dehydrated. Such symptoms may occur due to excessive water loss due to vomiting, diarrhea, or frequent urination. They may also occur if the patient has difficulty eating or drinking.
• If the patient is elderly with dementia and is taking risperidone.
• If the patient is elderly, taking other medicines that may cause low blood pressure, or has other diseases that increase the risk of low blood pressure.
• If the patient has (or may have) diabetes.
• If the patient has gout.
• If the patient has (or has had) liver or kidney disorders.
• If the patient has difficulty urinating, for example, due to an enlarged prostate.
• If the patient has low protein levels in the blood (hypoproteinemia), as it may reduce the effectiveness of the medicine and increase the risk of hearing damage.
• If the patient has high levels of calcium in the blood.
• If furosemide is to be given to a premature baby, as premature babies are more prone to kidney stone formation and therefore require close monitoring during treatment.

Furosemid hameln should not be used if the patient is scheduled to receive radiographic contrast media (as Furosemid hameln may increase the risk of kidney damage).
During treatment, it is necessary to monitor the patient's condition, including performing full blood counts to detect any blood disorders, measuring sodium, potassium, magnesium, calcium, chloride, bicarbonate, and kidney function tests (urea and creatinine levels in the blood), as well as measuring glucose and uric acid levels.

Furosemid hameln and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is especially important for any of the following medicines, as they may interact with Furosemid hameln.

• Medicines that support heart function (e.g. heart glycosides, such as digoxin). The doctor may need to adjust the dose of the medicine.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, flecainide, lidocaine, mexiletine, disopyramide, beta-adrenolytics (sotalol)).
• Medicines that lower blood pressure, especially so-called ACE inhibitors (ramipril, enalapril, perindopril), angiotensin II receptor antagonists (losartan, candesartan, irbesartan), and renin inhibitors (aliskiren).
• Other medicines used to lower blood pressure or treat heart disease, including diuretics that increase urine production (metolazone), calcium antagonists, hydralazine, minoxidil, toloxatone, nitrates, prazosin, clonidine, methyldopa, moxonidine, sodium nitroprusside.
• Lithium, used to treat mental illnesses.
• Medicines used to treat pain or inflammation (e.g. indomethacin, ketorolac, acetylsalicylic acid).
• Antibiotics belonging to the aminoglycoside group, polymyxins, vancomycin (risk of hearing or kidney damage), or cephalosporins, such as cefalexin and ceftriaxone. With trimethoprim, there is a risk of low sodium levels.
• Cisplatin used to treat cancer (increased risk of kidney damage).
• Methotrexate used to treat cancer, arthritis, psoriasis, or other autoimmune diseases - increased risk of furosemide toxicity.
• Cyclosporine used to prevent or treat organ rejection after transplantation.
• Aldesleukin used to treat kidney cancer.
• Medicines used to treat epilepsy, such as phenytoin, carbamazepine.
• Antihistamines (used to treat allergies).
• Corticosteroids used to treat inflammatory conditions.
• Muscle relaxants, such as baclofen and tizanidine, or curare-like medicines.
• Antipsychotic medicines (used to treat mental disorders) (pimozide, amisulpride, sertindole, or phenothiazines), tricyclic antidepressants, and monoamine oxidase inhibitors (medicines used to treat depression), sedatives and anxiolytics (chloral hydrate, triclofos), risperidone used to treat dementia, medicines used to treat attention deficit hyperactivity disorder (ADHD), such as atomoxetine (increased risk of hypokalemia and arrhythmias).
• Medicines used for general anesthesia to induce unconsciousness.
• Antidiabetic medicines.
• Antifungal medicines, such as amphotericin (risk of potassium loss).
• Levodopa used to treat Parkinson's disease (increased risk of low blood pressure).
• Concomitant use of oral contraceptives and estrogen-containing medicines may block the effect of furosemide.
• Medicines used to treat erectile dysfunction, such as alprostadil.
• Theophylline used to treat wheezing and breathing difficulties associated with asthma.
• Probenecid used to treat gout.
• Asthmatic medicines used in high doses, such as salbutamol, terbutaline, salmeterol, formoterol, or bambuterol.
• Medicines used to clear the nose, such as ephedrine and xylometazoline.
• Aminoglutethimide used to treat breast cancer.
• Laxatives used to treat constipation, such as bisacodyl, senna.

Furosemid hameln with food and alcohol

During treatment with Furosemid hameln, you should avoid drinking alcohol, as it may lead to excessive lowering of blood pressure.
Licorice used with Furosemid hameln may increase the risk of potassium loss.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The doctor will decide whether Furosemid hameln is suitable for you.
Furosemide passes into breast milk and may inhibit milk production. You should avoid breastfeeding while using Furosemid hameln.

Driving and using machines

If the administration of Furosemid hameln causes side effects, you should not drive or operate machinery.

Furosemid hameln contains sodium

This medicine contains a maximum of 100 mg of sodium (the main component of common salt) in each 25 ml solution (a maximum of 4 mg of sodium in each 1 ml solution). This corresponds to 5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Furosemid hameln

The injection will be given by a nurse or doctor.
The doctor will determine the dose suitable for the patient, the method, and time of administration of the medicine.
During treatment with Furosemid hameln, the doctor may recommend blood tests to ensure that the body maintains water and electrolyte balance.
If Furosemid hameln is used in a premature newborn (preterm baby), the doctor will monitor kidney function to ensure that Furosemid hameln does not have a negative effect on the kidneys.

Using a higher dose of Furosemid hameln than recommended

Since the injection will be given by a doctor or nurse, it is unlikely that the patient will receive too high a dose. If the patient thinks they have received too high a dose, they should tell the person administering the injection.
Symptoms of furosemide overdose include: low blood pressure (may cause dizziness, fainting, or pale skin), dehydration, concentrated blood, decreased sodium and potassium levels (detected by blood tests).
Due to fluid loss and electrolyte disturbances, the following may occur: significantly low blood pressure leading to shock, arrhythmias, severe kidney dysfunction, blood clots, decreased mental performance, muscle paralysis with loss of muscle tone, lack of emotions, and confusion.
After administration of furosemide in high doses, temporary hearing loss or a gout attack may also occur.
If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Furosemid hameln can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, tell your doctor or nurse immediately - you may need urgent medical attention.

Allergic reactions.
Allergic reactions can be severe and may include (severe) itching, rash, hives, (high) fever, difficulty breathing, cold, sweaty skin, pale skin, rapid heartbeat, sensitivity to light, red spots on the skin, joint pain, and (or) eye inflammation, diseases such as acute generalized exanthematous pustulosis (AGEP) or drug rash with eosinophilia and systemic symptoms (DRESS), characterized by severe acute (allergic) reaction with fever, blistering of the skin / peeling of the skin, and small spots caused by bleeding in the skin. Blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever may be symptoms of a disease called Stevens-Johnson syndrome. In a more severe form of the disease called toxic epidermal necrolysis (or Lyell's syndrome), the skin layers may peel off, leaving large areas of exposed skin on the body.
Severe abdominal pain radiating to the back - may be a sign of pancreatitis.
Symptoms of kidney inflammation, such as blood in the urine, pain in the lower back.
Acute kidney failure.
Easy bruising or bleeding, more frequent infections (e.g. sore throat, mouth ulcers, fever), feeling of weakness and fatigue greater than usual. Furosemid hameln may affect blood cell count, causing severe blood disorders.
Increased thirst, headache, dizziness, or feeling of dizziness, fainting, confusion, muscle pain or weakness, cramps, stomach upset, or arrhythmias. These may be symptoms of dehydration or electrolyte disturbances. Significant dehydration may lead to blood clots (especially in the elderly) or gout attacks.
Symptoms of metabolic acidosis, such as chest pain, arrhythmias, nausea, vomiting, weakness.
Jaundice or yellowing of the eyes and darker urine color. These may be symptoms of liver disorders. In patients with existing liver disease, a more severe form of the disease called hepatic encephalopathy may occur. Symptoms include memory disorders, seizures, mood changes, and coma.
Life-threatening loss of consciousness.

Tell your doctor or nurse as soon as possible if you experience any of the following side effects.

Hearing disorders or ringing in the ears (tinnitus) - especially in patients with existing kidney disorders.
Skin irritation, itching, feeling of tingling or numbness of the skin.
Mild mood changes, such as agitation or anxiety.
Dizziness, fainting, and loss of consciousness (caused by symptomatic hypotension), as well as headaches, concentration disorders, slowed reactions, feeling of drowsiness or weakness, vision disorders, dryness of the mouth mucosa. These may be symptoms of low blood pressure.
Vision disorders (blurred vision).
Vasculitis.

• Furosemid hameln may cause significant fluid loss (e.g. due to more frequent urination than usual) and electrolyte loss (sodium, potassium, magnesium, calcium) - frequency not known (cannot be estimated from available data).
• Symptoms of sodium deficiency include: dizziness, drowsiness, confusion, weakness, apathy, loss of appetite, muscle cramps.
• Symptoms of potassium deficiency include: muscle weakness and loss of muscle tone (paralysis), increased urination, heart disorders, in severe cases - gastrointestinal disorders or confusion leading to coma.
• Symptoms of magnesium and calcium deficiency include: increased muscle irritability, arrhythmias.

Tell your doctor or pharmacist if any of the following side effects worsen or persist for more than a few days, or if you experience any other side effects not listed in this leaflet.

Nausea or general malaise, diarrhea, vomiting, and constipation.
Pain when urinating in patients with bladder diseases and prostate diseases. The reason is the increased amount of urine produced.
Fluctuations in blood sugar levels in patients with diabetes.
Passing more urine than usual, usually occurring 1 or 2 hours after taking the medicine.
Pain at the injection site, in the case of intramuscular injection.
Hearing loss (deafness), which may sometimes be irreversible.
Blood tests
Furosemid hameln may affect liver enzyme activity or blood lipid levels, such as cholesterol and triglycerides, but these values usually return to normal within 6 months.
Additional side effects in children
After using furosemide in premature babies, cases of calcium deposition in the kidneys and heart defects, such as persistent ductus arteriosus, have been reported.
If you have any doubts about using this medicine, talk to your doctor or nurse.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to
the Department of Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301 Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Furosemid hameln

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule or carton.
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use this medicine if the solution for injection contains visible particles or if its color has changed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Furosemid hameln contains

• The active substance is furosemide. Each 1 ml solution contains 10 mg of furosemide. Each 2 ml solution contains 20 mg of furosemide. Each 4 ml solution contains 40 mg of furosemide. Each 5 ml solution contains 50 mg of furosemide. Each 25 ml solution contains 250 mg of furosemide.
• The excipients are sodium chloride, sodium hydroxide (for pH adjustment), and water for injections.

What Furosemid hameln looks like and contents of the pack

Furosemid hameln is a clear, colorless to slightly brownish-yellow solution without visible particles.
The 2 ml, 4 ml, 5 ml, or 25 ml solution is supplied in orange glass type I ampoules with one point (OPC).
The following pack sizes of Furosemid hameln are available:
5 or 10 ampoules of 2 ml in a carton
5 or 10 ampoules of 4 ml in a carton (in 5 ml ampoules)
5 or 10 ampoules of 5 ml in a carton
5 or 10 ampoules of 25 ml in a carton
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
hameln pharma gmbh, Inselstraße 1, 317 87 Hameln, Germany
Manufacturer / Importer:
Siegfried Hameln GmbH, Langes Feld 13, 317 89 Hameln, Germany
HBM Pharma s.r.o., Sklabinská 30, 036 80 Martin, Slovakia
hameln rds s.r.o., Horná 36, 900 01 Modra, Slovakia
Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: 2024-03-20

-----------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:

PREPARATION GUIDELINES:

Furosemid hameln, 10 mg/ml, solution for injection

Furosemid hameln is a clear, colorless to slightly brownish-yellow solution without visible particles.
pH 8.0-9.3
Administered intravenously or intramuscularly.

Incompatibilities

Furosemide should not be mixed in a syringe with other medicines, as it may precipitate when mixed with dobutamine, diazepam, doxorubicin, droperidol, gentamicin, glucose, mannitol, metoclopramide, potassium chloride, tetracycline, vincristine, and vitamins.
Furosemide should not be administered during infusion with adrenaline, isoprenaline, lidocaine, or pethidine.

Dilution

Furosemid hameln can be diluted in 5% glucose solution (50 mg/ml), 0.9% sodium chloride solution (9 mg/ml), or Ringer's solution.

Shelf life

Unopened ampoules: 3 years.
Opened ampoules: the medicine should be used immediately after opening the ampoule.
Prepared infusion solutions: chemical and physical stability has been demonstrated for 72 hours at 25°C, when diluted in 5% glucose solution (50 mg/ml), 0.9% sodium chloride solution (9 mg/ml), or Ringer's solution.
From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Normally, the storage time should not exceed 24 hours at 2°C to 8°C, unless the solution has been prepared in controlled and validated aseptic conditions.